The US fate of the Sapien transcatheter aortic heart valve remains unknown this Halloween night. Despite previous statements from Edwards Lifesciences that projected an October US launch of their TAVI device, no word has yet been received concerning approval of the device in the US.

We are fully prepared to begin U.S. launch of SAPIEN for inoperable patients and expect FDA approval any day.

It is worth noting here that unlike drugs, which have firm PDUFA dates, devices do not have the same sort of absolute deadlines for FDA decisions. As best I can tell, although the FDA may reach agreements with companies about deadlines, neither the companies not the FDA are obligated to disclose this information.

Estragon: I can’t go on like this.Vladimir: That’s what you think. (Waiting for Godot)